Sputnik V vaccine production in India: Serum Institute gets DGCI nod for manufacturing Russian vaccine

In a big shot in the arm to India's vaccine production, Drug Controller General of India (DCGI) has given approval for manufacturing life saving Covid-19 vaccine Sputnik V to the Serum Institute of India (SII). The nod from the regulatory body came only a day after the SII had expressed interest and applied for manufacturing the Russian coronavirus vaccine. 

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After DGCI approval, SII CEO Adar Poonawalla welcomed the efforts of India's Ministry of External Affairs S Jaishankar and the US President Joe Biden for lifting restrictions on manufacturing of COVID-19 vaccine.  

Taking to Twitter, Poonawalla posted, “...this policy change will hopefully increase the supply of raw materials globally and to India; boosting our vaccine production capacity and strengthening our united fight against this pandemic." 

Thanks to the efforts of @POTUS, @WhiteHouse, & @DrSJaishankar, this policy change will hopefully increase the supply of raw materials globally and to India; boosting our vaccine production capacity and strengthening our united fight against this pandemic. https://t.co/bHADBwiUnm

— Adar Poonawalla (@adarpoonawalla) June 4, 2021

This approval from DGCI to manufacture, test and analysis came with certain conditions. 

"The DCGI has granted permission to the Serum Institute to manufacture the Sputnik Covid-19 vaccine in India for examination, test, and analysis at its licensed Hadapsar facility with certain conditions," news agency PTI reported, citing official sources.  

SII is reportedly collaborating with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, Russia, for developing Sputnik V. 

As per the conditions laid out by DGCI before SII, the Serum Institute will have to submit a copy of the agreement between it and the Gamaleya Research Institute of Epidemiology and Microbiology for transfer of cell bank and virus stock and submit the copy of agreement for technology transfer with Gamaleya.  

DGCI also asked SII to submit a copy of the RCGM permission to import cell bank and virus stock and a copy of the RCGM permission to initiate research and development of viral vector vaccine Sputnik V, the report said. 

Russia's Sputnik V vaccine is currently being manufactured by Dr Reddy's Laboratories in India.